Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472225
Status:
UNKNOWN
Last Update Posted:
2009-02-24
First Post:
2007-05-10
Brief Title:
Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
Sponsor:
The Korean Society of Hematopoietic Stem Cell Transplantation
Organization:
The Korean Society of Hematopoietic Stem Cell Transplantation
Study Overview
Official Title:
Open-Labelled Multicenter Phase II Study of Rituximab in Patients With Steroid-Refractory Chronic Graft-Versus-Host Disease
Status:
UNKNOWN
Status Verified Date:
2009-02
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic GVHD is the most common late complication following allogeneic stem cell transplantation It has features resembling autoimmune disorders such as scleroderma primary biliary cirrhosis bronchiolitis obliterans chronic immunodeficiency etc Thus chronic GVHD can lead to debilitating complications such as joint contractures blindness end-stage lung disease etc so that chronic GVHD has a major impact both on survival as well as quality of life Although its pathogenesis is still poorly unclear it has been reported since 2000 that B cell-mediated immunity may also contribute to development of chronic GVHD other than T cells Thus targeting against B cell may be a useful treatment strategy in the treatment of chronic GVHD
The purpose of this study is to determine whether rituximab an anti-CD20 monoclonal kimeric antibody is effective in the treatment of chronic graft-versus-host disease chronic GVHD refractory to steroid
The purpose of this study is to determine whether rituximab an anti-CD20 monoclonal kimeric antibody is effective in the treatment of chronic graft-versus-host disease chronic GVHD refractory to steroid
Detailed Description:
1 STUDY OBJECTIVES
Primary Endpoints To assess the response rate
Secondary End points
To evaluate the discontinuation of corticosteroid
To assess the quality of life
2 Treatment schedule
The BSA on the date of every treatment cycle may be used as the same value of baseline BSA if change of body weight is within 10 of baseline body weight
Treatment schedule consists of induction and maintenance therapy as follows
Induction - Rituximab 375 mgm2 weekly IV for 4 consecutive weeks
Maintenance - Rituximab 375 mgm2 monthly IV for 4 consecutive months
Primary Endpoints To assess the response rate
Secondary End points
To evaluate the discontinuation of corticosteroid
To assess the quality of life
2 Treatment schedule
The BSA on the date of every treatment cycle may be used as the same value of baseline BSA if change of body weight is within 10 of baseline body weight
Treatment schedule consists of induction and maintenance therapy as follows
Induction - Rituximab 375 mgm2 weekly IV for 4 consecutive weeks
Maintenance - Rituximab 375 mgm2 monthly IV for 4 consecutive months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None